The best outcomes for meniscal repair come from establishing the correct reduction of the torn tissue. In an arthroscopic procedure, the meniscus is often difficult to access and more difficult to repair. This is the case because of the risk of neurovascular injury. Presently, the methods that represent the gold standard of repair are sutured based. Methods having the cheapest cost involve a suture that is shuttled using long needles and cannulas as guides. Such a method involve making two incisions, one anterior and one posterior to the direction of the needle. It should be noted that such a method is not without risk of neurovascular injury. In addition, such methods also require the tying of knots arthroscopically and thereafter cutting of the suture, also arthroscopically. Another technique involves the use of a hybrid in which sutures are shuttled through spinal needles. While such methods are relatively inexpensive from the standpoint of the cost of materials and devices being used, these methods are necessarily labor intensive.
A number of products also have been developed, in which the suture is configured with pre-tied knots or the product includes the use of staples and tacks. A number of the suture based techniques also involve the use of an implant or suture anchor that is coupled to the suture. As is known in the art, the combined implant and suture are used to repair the damaged meniscus.
More particularly, a unique surgical device or surgical instrument is typically provided that is specifically configured and/or designed to deploy the implants or suture anchors for a meniscal or other tissue repair. Such a device/instrument includes a handle and a tubular assembly extending from the handle having a sharp distal end for insertion into the tissue. The tubular assembly is further configured so that one or two implants or the like that are connected to a suture(s), are slidably disposed in the tubular assembly. The surgeon uses the handle to manipulate the device to insert the sharp distal end into and through the tissue (e.g., meniscus). After such insertion, each implant is either passively or actively deployed. In passive deployment, the implant is withdrawn from the tubular assembly as the implant interacts with the tissue during a withdrawal motion of the device. In active deployment, the surgeon takes some action (e.g., pushes on a slide) that applies a force to the implant so it is pushed out of the tubular assembly.
If the device includes a second implant, the device is manipulated so as to cause the second implant to move from its storage position to the pre-deployment location in the tubular assembly. The device is again inserted into the tissue but most likely to a different tissue location and the second implant is deployed. The surgeon then takes the appropriate actions to tighten the suture and also to remove the device that was used to deploy the implants. After securing the implants and tightening the suture, the surgeon typically inserts a suture cutting device to cut the suture and typically remove the excess length of suture. As these sutures are pre-tied, the sutures are arranged so that when the surgeon applies a longitudinal force to the suture this shortens the suture and tightens the knot.
The tubular assembly also is typically provided in different configurations (e.g., straight distal end, curved or offset distal end) to facilitate implant deployment at different tissue locations. This means that a unique device is built for each configuration or different tubular assemblies are constructed for each configuration and these are separately mounted to a handle or handle assembly.
There is found in U.S. Publication No. 2013/0053884, a closure system for closing openings in tissue, where such a system includes a closure device and a fastener. Such a closure device also includes shafts that are configured to deploy the fastener to close the opening in the tissue. Such a closure device also includes shafts that are configured to deploy the fastener 500 to close the opening in the tissue. The fastener includes an opening that is formed therein and the sutures are received or drawn through the opening. Also, the closure device includes an outer shaft and an actuator (inner) shaft that are configured to deploy the fastener as either a knot replacement or a knot pusher. Further, the closure device is configured to trim the sutures after deployment. More particularly, the closure device includes cutters formed or included in the outer and actuator shafts that are configured to trim the sutures by relative movement of the outer and actuator shafts.
There is found in U. S. Publication No. 2004/0002734, which corresponds to U.S. Pat. No. 6,972,027, a suture anchor delivery system including a handle and a needle extending therefrom. Such a suture anchor delivery system also includes a suture anchor assembly that is slidably received on the needle. In a particular embodiment such a suture delivery system includes an insertion device and a suture anchor assembly disposed thereon. The suture delivery system also is configured for inserting suture anchors of the suture anchor assembly into soft tissue so as to subsequently facilitate repair of the soft tissue, such as the meniscus, tendons, ligaments, muscles, or the like. In the loaded state, the suture anchors are mounted on the needle.
There is found in U. S. Publication No. 2008/0091219, which corresponds to U.S. Pat. No. 7,918,868, an apparatus for suturing tissue, wherein the apparatus includes: a housing; a first needle mounted to the housing; a second needle mounted to the housing; a suture having a leading portion and a trailing portion; a first structure associated with the first needle for passing the leading portion of the suture from a near side of the tissue to a far side of the tissue; and a second structure associated with the second needle for retracting the leading portion of the suture from the far side of the tissue back to the near side of the tissue. Also included is a pre-formed, un-cinched knot formed in the trailing portion of the suture; and a support for releasably supporting the pre-formed, un-cinched knot relative to the housing.
Also found is a method for suturing tissue, the method including: providing a suture having a leading portion and a trailing portion, wherein a pre-formed, un-cinched knot is formed in the trailing portion of the suture; passing the leading portion of the suture from a near side of the tissue to a far side of the tissue; retracting the leading portion of the suture from the far side of the tissue back to the near side of the tissue; passing the retracted leading portion of the suture through the pre-formed, un-cinched knot formed in the trailing portion of the suture; and cinching the knot so as to secure the suture in the tissue.
There is found in U. S. Publication No. 2006/0009765, which corresponds to U.S. Pat. No. 7,632,284, an instrument kit for performing a repair on a meniscal tear. Such a kit includes at least one instrument or template that can be inserted within the knee area along a path adjacent to the tear and used to at least partially repair the meniscal tear. The instrument kit also can include a handle adapted to be removable attached to a proximal end of the template. The instrument kit for performing a repair procedure on a meniscal tear in a knee is used in combination with a meniscal repair device.
Such an instrument kit includes at least one template having an elongate body defining X, Y and Z axes. Preferably, the elongate body is adapted for insertion in a knee of the patient to approximate a path to a meniscal tear. The elongate body has a length along the X-axis sufficient to access the meniscal tear and a reduced profile to facilitate passage thereto. Upon subsequent removal of the template from the knee, a correspondingly dimensioned meniscal repair device is introduced along the path to the meniscal tear for repair using the opening formed by the template.
Such an instrument kit may further include a handle that is configured and adapted to be removably attached to a proximal end of each of the at least one template. Alternatively, the handle can be either integrally formed with or fixedly secured to a proximal end of the at least one template. Also found is a method of performing a repair procedure or a meniscal repair in a knee. Such a method includes introducing a selected elongate template within the knee area of a patient to approximate a path to a meniscal tear within the knee (e.g., grossly defines a path through the knee to the target site).
There is found in U. S. Publication No. 201110160767, which corresponds to U.S. Pat. No. 8,337,525, a fibrous tissue repair device including first and second tubular anchors having corresponding longitudinal passages and corresponding first and second inserters. Each inserter has a shaft with a distal portion received in the longitudinal passage of the corresponding tubular anchor. A flexible strand couples the first and second anchors. Also found is a kit for repairing soft tissue which may be used for meniscus repairs. While the description and drawing figures are illustrated in an application for meniscus repair in knee surgery, it also is provided that the teachings also can be used for repairing any fibrous tissue, such as muscle, ligament or tendon in an arthroscopic or other open procedure, including rotator cuff reconstruction, acromioclavicular (AC) reconstruction, anterior cruciate ligament reconstruction (ACL) and generally for fastening tendons, grafts, or strands to fibrous tissue and bone.
There is found in U. S. Publication No. 2009/0228041, an arthroscopic meniscal tear repair device including a catch needle and a transfer needle, which are both pierced into a torn meniscus and advanced past the tear. A suture is transferred by a suture needle from the transfer needle through the meniscus and into the catch needle. The catch needle has an internal mechanism that retains the suture. The suture needle is then retracted back to its home position inside the transfer needle, leaving the free end of the suture across the meniscus and in the catch needle. The device is then retracted out of the meniscus, leaving behind a stitch across the meniscal tear inside the meniscus. A pre-tied knot of suture is then slid down the device and cinched up using a knot pusher having a dilation tip, thus completing the repair. Also found is a system for repairing meniscal tear which may include sliding a pre-tied knot suture with a pusher. The pusher may be kitted with the device as a separate component. It also is provided that the geometry of the knot pusher, in particular, is unique relative to other minimally invasive surgical knot pushers because of the dilation tip.
As indicated in above discussion, each of the above described systems, methods and devices utilize a uniquely constructed suture anchor delivery device to localize a suture anchor with respect to the targeted area and then deliver the suture anchor to the targeted area. This necessarily increases the part count associated with any kit as well as requiring the controlled manufacture and storage of such devices.
It thus would be desirable to provide an implant deployment/delivery module/device that is adaptable for use with another surgical device such as a suture cutter and which can utilize functionalities of such another surgical device or suture cutter in the process of localizing the implant/anchor with respect to the targeted area device as well as delivering or deploying the implant/anchor to the targeted area. Such an implant deployment device/module preferably does not increase the level of difficulty to the users as compared to methods embodying the use of conventional delivery/deployment devices. Such an implant deployment/delivery module/device also preferably should not be more costly that the conventional devices.